Prognostic Value of the CINSARC (Complexity Index in Sarcoma) Signature and Correlation With Chemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study. (NEOSarcomics )
This is a prospective observational biomarker study including patients with non-metastatic, soft-tissue sarcomas (STS) for whom neoadjuvant chemotherapy is considered as the best option by the multidisciplinary sarcoma team of one of the participating centers.
• Histologically confirmed soft-tissue sarcoma by central review, except if the diagnosis was already confirmed by the RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) Network,
• Available archived frozen tumor tissue sample or patient consenting to undergo a biopsy of the tumour for research purpose,
• Non-metastatic disease, for which the use of chemotherapy to downstage the sarcoma prior to surgery, is assumed to result in better local tumor control by the multidisciplinary sarcoma team of one of the French reference centers involved in this study,
• Age ≥ 18 years,
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1,
• Measurable disease according to RECIST v1.1 outside any previously irradiated field,
• Neoadjuvant anthracycline-based chemotherapy proposed as the best option by the multidisciplinary sarcoma team of one of the French reference centers involved in this study,
• No prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,
• Voluntarily signed and dated written informed consents prior to any study specific procedure,
⁃ Patients with a social security in compliance with the French Law relating to biomedical research (Article 1121-11 of French Public Health Code).